Draft licence GE Healthcare in Leiderdorp for new pharmacy for radiopharmaceutical products
The Authority for Nuclear Safety and Radiation Protection intends to grant a licence to GE Healthcare for a new radiopharmaceutical pharmacy at Simon Smitweg 3A in Leiderdorp. At this pharmacy, GE Healthcare will be producing medicinal products, called radiopharmaceutical products, that contain ionising radiation. Physicians in hospitals use these medicinal products to detect cancer in the body for example. In a draft licence, we indicate how this company can ensure safe handling of the radioactive materials contained in these medicinal products. Anyone can respond to the draft licence up to and including the 21st of February 2024.
Leiderdorp: location for the processing and distribution of radiopharmaceutical products
GE Healthcare’s headquarters are located in Eindhoven. That is where the company produces radiopharmaceutical products for Dutch hospitals. Part of the production of the medicinal products currently taking place in Eindhoven will be moving to the GE Healthcare location in Leiderdorp. From there, they will be distributed to the hospitals. Temporary storage will take place at the Leiderdorp site. Some radiopharmaceutical products are not yet ready for use when they arrive from Eindhoven. They are then further processed in one of the laboratories in Leiderdorp.
What is GE Healthcare receiving permission for?
GE Healthcare was required to demonstrate that they can safely handle the radioactive materials needed to produce these medicinal products in Leiderdorp. This includes processing radioactive materials in the three laboratories on site. They also needed to show that the temporary storage complies with safety requirements; such as fire safety. The licence also states how they should deal with radioactive waste.
In these activities involving radioactive materials, ionising radiation can be released. In order to be granted the licence, GE Healthcare was required to show how they would ensure that the amount of radiation remains below the statutory limits. These limits ensure that the use of the radioactive materials is safe for workers and the environment for example.
They are also using sealed radioactive sources, for reasons including taking measurements. Sealed means that the source is attached to a protective material, preventing dispersal to the environment. The licence states how they should deal with this, also in terms of storage.
Read and respond up to and including 21 February 2024
The draft decision (in Dutch) of the licence for GE Healthcare can be reviewed up to and including the 21st of February 2024. If you have any comments after reading the draft decision, then you can submit an objection.
There are 3 ways to respond:
- By email: send your email to Postbus.Aanvragenenmelden@anvs.nl and put ‘objection to the GE Healthcare draft licence’ in the subject line of your email.
- By post: send a letter to The Authority, Objection to the GE Healthcare draft licence, P.O. Box 16001, 2500 BA The Hague.
- By telephone: call the Information Desk for Nuclear Energy Act licences at +31 88 489 05 00. We are available from Monday to Friday between 8.30 and 17.00.
We will respond to these objections once a definitive decision has been made in regards to the GE Healthcare licence application. We will include your objections and our response to these objections in our definitive decision. This decision will then also be published on our website. When you have submitted an objection, you will receive a copy of the definitive licence.
Would you like to know more?
Please read the notification in the Government Gazette (in Dutch). For more information on radioactive medicinal products, see the topic medical isotopes (in Dutch) on this website.